OsteoporosisNCT00302484
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
A study testing Zoledronate in people with Osteoporosis and Liver Transplantation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Liver Transplantation
- What is being tested?
- Zoledronate
- How many people
- 96 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2002to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary liver transplantation
- retransplantation within two weeks
- written informed consent
- Age ≥ 18 years
Who cannot join
- chronic kidney disease:
- Creatinine Clearance < 35 ml/min or Serum Creatinine > 2,5 mg/dl
- known hypersensitivity to Zoledronate, or any of the recipients of the drug
- bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Surgery, Division of Transplantation
Vienna, State of Vienna, A-1090
About this study
Official title: Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.
- Conditions
- Osteoporosis, Liver Transplantation
- Being tested
- Zoledronate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoledronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
first bone fracture or death within 24 months after liver transplantation
Secondary outcomes (3)
bone mineral density (pre-transplant, 6 and 12 months post-transplant)
serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ferdinand Mühlbacher, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302484
- Sponsor's protocol ID
- LTX-BISPHO-01
- Status last verified
- Jan 2006
- First submitted
- 13 Mar 2006
- Last updated
- 26 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT00302484
- Acronym / sponsor ID
- LTX-BISPHO-01
- Conditions
- Osteoporosis, Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2002
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary liver transplantation
- retransplantation within two weeks
- written informed consent
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- chronic kidney disease:
- Creatinine Clearance < 35 ml/min or Serum Creatinine > 2,5 mg/dl
- known hypersensitivity to Zoledronate, or any of the recipients of the drug
- bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronate | Drug | – |
Primary outcome
first bone fracture or death within 24 months after liver transplantation
3 secondary outcomes
bone mineral density (pre-transplant, 6 and 12 months post-transplant)
serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdinand Mühlbacher, M.D. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoledronate in people with Osteoporosis and Liver Transplantation, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first bone fracture or death within 24 months after liver transplantation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2006.